Digital Transformation through eSignature in GxP processes

Learn how USDM deployed DocuSign’s Part 11 compliant solution to help a global biotech move an arduous, paper-based learning management practice into a compliant digital process. The initial use case was deployed in 18-days and was a highly successful case study for the first step on their digital transformation journey.  

The Situation

  • Commercial biotech company
  • $11B annual revenue with over 10 therapies commercially available
  • Paper based Learning Management Systems required users to print, sign and scan/fax/email form
  • Relying on team to return paper based / wet signature training records took days to weeks to complete
  • Existing cloud platform (Salesforce) provided foundation to easily add on e-signature solution (DocuSign)

The Solution

USDM’s Cloud Assurance team implemented and validated DocuSign’s Part 11 module in 18 days. An integration with Salesforce and the customer’s learning management system boosted the impact, creating a connected, compliant, end-to-end digital process with unmatched speed and transparency.

  • Legacy process replacement with high impact and ROI (approx. $50 savings per signature hundreds of signatures per month)
  • DocuSign is now available and easily expandable to other GxP processes, adding value throughout the organization
  • End-to-end compliance assurance from USDM
  • 77% faster implementation of CSV program and application validation
  • Training record submissions drop from a week to less than a day

80% faster submission of training records

$300k ANNUAL productivity savings

Digital Transformation launched with DocuSign and Salesforce

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